BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIOLIMUS-ELUTING CORONARY STENT

    MDR report key: 1061317 · Received June 13, 2008

    Report

    Report Number
    9616099-2008-01515
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 17, 2008
    Report Date
    May 19, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PATIENT WAS RANDOMIZED TO THE REGISTRY FOR ONE VESSEL DISEASE. A STAGED PROCEDURE WAS NOT PLANNED. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA PECTORIS. THE FIRST TARGET LESION WAS AT THE MID-RCA. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 3.0MM AND LESION LENGTH WAS 15MM. THE LESION WAS DENOVO, WITH NO MAJOR SIDE BRANCH INVOLVEMENT. PRE-PROCEDURE DIAMETER STENOSIS WAS 100% AND POST PROCEDURE STENOSIS IS UNKNOWN. TIMI FLOW PRE AND POST PROCEDURE IS ALSO UNKNOWN. LESION CLASSIFICATION WAS TYPE B1. PREDILATATION WAS PERFORMED USING A 2.0X18MM BALLOON AT 12ATMS. A DEVICE WAS DEPLOYED AT 14 ATMS. POST DILATATION WAS NOT PERFORMED. IVUS WAS NOT USED. THE SECOND TARGET LESION WAS AT THE DISTAL RCA. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 2.75MM AND LESION LENGTH WAS 12MM. THE LESION WAS DENOVO, WITH NO MAJOR SIDE BRANCH INVOLVEMENT. PRE-PROCEDURE DIAMETER STENOSIS WAS 100% AND POST PROCEDURE STENOSIS WAS ZERO PERCENT. TIMI FLOW PRE AND POST PROCEDURE IS ALSO UNKNOWN. LESION CLASSIFICATION WAS TYPE B1. PREDILATATION WAS PERFORMED USING A 2.0X18MM BALLOON AT 12ATMS. A CRB18275 WAS DEPLOYED AT 14 ATMS. THE PT WAS DISCHARGED ON 325MG ASPIRIN, 150MG CLOPIDOGREL, LOW-MOLECULAR HEPARIN, STATINS, AND ACE-INHIBITORS. DURING THE ONE-MONTH FOLLOW-UP THE PT WAS ASYMPTOMATIC AND COMPLIANT WITH ANTIPLATELET REGIMEN. THE DEVICE INVOLVED IN THIS EVENT IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CYPHER SIROLIMUS-ELUTING CORONARY STENT.

    Description of Event or Problem · 1

    NOTIFICATION WAS RECEIVED FROM THE REGISTRY INDICATING THAT APPROXIMATELY FOUR MONTHS POST INDEX PROCEDURE (2008), THE PT UNDERWENT REVASCULARIZATION TO THE TARGET LESIONS. THE PT WAS SEEN DURING AN UNSCHEDULED VISIT, AND HE WAS TROPONIN POSITIVE FOR INDUCED ISCHEMIA. A CORONARY ANGIOGRAM WAS PERFORMED. THERE WAS NO EVIDENCE OF MYOCARDIAL INFARCTION. THE ANGIOGRAM SHOWED IN-STENT RESTENOSIS OF THE STENT IN THE MID RCA AND THIS WAS PROBABLY DUE TO A STENT FRACTURE AT THE SITE. ADDITIONAL INVESTIGATION INDICATED, THE STENT DID NOT SEPARATE INTO TWO SEPARATE PARTS AND THERE WAS NO MIGRATION. THE EVENT WAS TREATED WITH ANOTHER DRUG ELUTING STENT; UNKNOWN BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIOLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13302068

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R CRB18275 CYPHER SELECT PLUS STENT AND| 2.0X18 MM BALLOON